Quality System Analyst

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Previa verifica dei requisiti professionali, costituisce titolo preferenziale l'appartenenza alle Categorie Protette ai sensi dell'art 1 L. 68/99 e/o alle categorie di lavoratori che risultino percettori di interventi a sostegno del reddito e/o risultino disoccupati a seguito di procedure di licenziamento collettivo.

OBJECTIVES/PURPOSE:

• Provide Quality support to Commissioning, Qualification and Verification (CQV) and validation activities to ensure compliant execution, accurate documentation, and maintenance of the validated state in line with cGxP and site procedures.

• Support Quality System & Compliance activities (QMS processes, documentation, inspection readiness) by executing assigned tasks and coordinating actions with cross-functional stakeholders.

• Support laboratory validation activities (e.g., qualification/validation of laboratory instruments and relevant computerized systems/processes) ensuring traceability to requirements and proper recordkeeping.

• Support Data Integrity practices by applying good documentation practices and assisting with routine activities such as access checks, audit trail review support, and periodic review preparation.

ACCOUNTABILITIES: 

• Support preparation, execution follow-up, and documentation of CQV/validation activities for facilities/utilities/equipment and computerized systems (as applicable).

• Compile, route, and archive validation documentation and evidence packages; perform completeness checks of executed records and coordinate corrections.

• Support user requirements review and traceability to verification evidence; escalate gaps and risks.

• Support deviations/exceptions, change controls and inspection readiness activities related to validation and quality system topics.

• Support laboratory validation documentation and readiness activities.

• Support Data Integrity activities including audit trail review support, access checks support, and periodic review package preparation.

• Execute validation documentation workflows using Kneat (e.g., drafting/routing, reviews/approvals, tracking, and archival support).

CORE ELEMENTS RELATED TO THIS ROLE: 

• Provides structured support to CQV/validation and Quality System activities by ensuring high-quality, inspection-ready documentation and disciplined follow-up of actions.

• Applies Data Integrity and GDP/ALCOA+ principles in daily work (documentation, traceability, record completion checks, audit trail review support, periodic review support).

• Uses Kneat to execute validation documentation workflows (drafting, routing, review/approval support, tracking, and archival readiness).

• Demonstrates a learning mindset and continuous improvement orientation, contributing to simplification and standardization of validation and QMS processes.

DIMENSIONS AND ASPECTS:

Technical/Functional (Line) Expertise

• Basic knowledge (or willingness to learn) of pharmaceutical quality systems and regulated environments (cGxP), including good documentation practices (GDP) and Data Integrity principles (ALCOA+).

• Supports CQV/validation activities by compiling and checking documentation packages (e.g., protocols, reports, traceability matrices, risk assessments) and ensuring inspection-ready records.

• Supports laboratory validation/qualification activities by organizing evidence and performing completeness checks for lab equipment and laboratory computerized systems/processes, as applicable.

• Uses electronic validation workflows (e.g., Kneat) for drafting/routing, review support, tracking, and archival readiness of validation documentation.

Leadership

• Demonstrates accountability for assigned tasks, with a proactive attitude to learn, ask questions, and seek guidance when needed.

• Communicates clearly and collaborates effectively with cross-functional stakeholders to support on-time delivery and compliant documentation.

• Supports change initiatives by adopting new processes and tools (e.g., digital validation workflows) and contributing improvement ideas.

Decision-making and Autonomy

• Works independently on routine tasks following SOPs and templates; escalates deviations, data integrity concerns, and documentation gaps to the responsible lead in a timely manner.

• Supports data collection and preparation of summaries (e.g., trackers, action lists, periodic review inputs) to enable informed Quality decisions.

Interaction

• Supports daily collaboration with Quality, QA, QC, Production, Engineering, Warehouse, IT and Automation to coordinate CQV/validation documentation, trackers, and action follow-up.

• Coordinates with peers and other site contacts to share templates, standard approaches, and lessons learned, under supervision

Innovation

• Participates in continuous improvement initiatives by proposing simplifications to templates, trackers, and documentation flows while maintaining compliance.

Complexity

Supports site compliance by contributing to CQV/validation and Quality System activities across multiple stakeholders and documentation types, following established procedures and escalating issues as needed.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: 

• Technical or scientific degree (or equivalent background/experience).

• Experience in a regulated environment is desirable (internship/apprenticeship acceptable).

• Basic knowledge (or willingness to learn) cGxP/cGMP and quality system principles.

• Basic understanding (or willingness to learn) Data Integrity and GxP/ALCOA+ principles.

• Ability to support CQV/validation documentation activities (including laboratory validation) with strong attention to detail.

• Basic understanding of investigation fundamentals and structured problem solving (training supported).

• Basic knowledge of statistics and simple data trending/reporting is desirable.

• Good digital skills; familiarity with data visualization tools (e.g., Power BI) is desirable.

• Good English language skills (written and spoken).

• Strong communication, organization, and teamwork skills; proactive learning mindset.